HA Pins (DFS HA Cort Screw), Hoffman/Colles Pins (Colles CSER Sterile w/ Pin Kit)
Medical device recall Z-0528-2020. Published in FDA’s Enforcement Report on Dec 4, 2019.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Dec 4, 2019. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Nationwide FDA’s word for where it went
- 178886 how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
HA Pins (DFS HA Cort Screw), Hoffman/Colles Pins (Colles CSER Sterile w/ Pin Kit) Item Nos: HAA60-09030 HAA60-09040 HAA60-10030 HAA60-10040 HAA60-11030 HAA60-11040 HAA60-11050 HAA60-12040 HAA60-12060 HAA60-13030 HAA60-13040 HAA60-13050 HAA60-13060 HAA60-13070 HAA60-14050 HAA60-14080 HAA60-14090 HAA60-15020 HAA60-15030 HAA60-15040 HAA60-15050 HAA60-15060 HAA60-16030 HAA60-16040 HAA60-16050 HAA60-16070 HAA60-16090 HAA60-17040 HAA60-17060 HAA60-17080 HAA60-18010 HAA60-18030 HAA60-18040 HAA60-18050 HAA60-18060 HAA60-18090 HAA60-20030 HAA60-20040 HAA60-20050 HAA60-20060 HAA60-20080 HAA60-20090 HAA60-22050 HAA60-22060 HAA60-25030 HAA60-25040 HAA60-25050 HAA60-25060 HAA60-30060 HAB60-09030 HAB60-10030 HAB60-10040 HAB60-11040 HAB60-11050 HAB60-12040 HAB60-12060 HAB60-13040 HAB60-13050 HAB60-13060 HAB60-14050 HAB60-15060 HAB60-16070 HAB60-16090 HAB60-17080 HAB60-18010 HAB60-18090 HAB60-20080 HAB60-20090 808200000 Product Usage: These devices are intended for osteosynthesis, external fixation of fractures or bone lengthening procedures.
178886, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Lots 089610 241030 089600 241020 238180 416260 507280 450740 314580 736790 779690 889140 836030 970200 444550 984630 316530 198990 419500 431591 444655 459030 633280 921380 148200 441530 718410 884690 856150 444530 066610 352090 553250…
Every code shown here, 1,998 characters
Lots 089610 241030 089600 241020 238180 416260 507280 450740 314580 736790 779690 889140 836030 970200 444550 984630 316530 198990 419500 431591 444655 459030 633280 921380 148200 441530 718410 884690 856150 444530 066610 352090 553250 HA109-05 148190 666010 825420 989490R 989490 444510 444510R 984610 241410 390410 152390 316520 390410R 432706 484710 484720 238170 427280 450730 323210 507270 748450 789870 877610 002130 444500 984600 363080 670430 136700 198960 198970 230290 230300 413443 413444 432705 984600R 148180 441520 456560 732840 825410 889130 970190 444420 984580 921390 530950 120230 198910 198930 230280 413441 803810 803810R 086800 357830 740750 921550 450720 323200 640280 718400 856140 946100 444470 057550 386080 303010 633210 403720 516120 418870 824120 592130 148930 017430 802520 274630 966250 966260 047790 351330 822190 846490 131420 131430 912600 965370 277220 314570 450710 771080 856130R 856130 988850 251590 444450 621070 147070 530940 120220 198850 341593 419499 422450 450710R 633250 831320 089680 340980 241400 118720 441510 516910 771070 836020 835980 444140 066600 120210 198820 436780 697210 722780 238160 375410 375410R 344370 441500 456550 825400 831310 884680 924720 946090 989480 242060 444120 984570 524230 524230R 559330 628180 017420 110510 139030 198790 230260 230270 349160 428342 428608 432704 553220 553230 553240 671740 671750 803800 237530 541190 427240 740740 064900 003150 314520 148170 456540 338850 507260 547070 659870 630650 775690 889120 779680 804350 856120 946080 970180 002120 004740 251580 444100 007640 333720 449860 102550 194590 194600 237250 418830 774130 110710 273080 638390 141600 950170 950130 484730 484680 524220 621770 785560 210030 714850 717010 966230 717130 152420 002370 949680 949690 068340 120400 131400 131410 230310 230320 2375300 341591 349159 418581 432702 439398 619620 799540 921370 237520 427220 826470 118710 328020 405050 450700 483680 547060 640270 713900 856110 789860 889110 889100 989470 004730 242050 251570…
FDA’s list runs to 45,998 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
US Nationwide distribution and countries of Argentina, Australia, Brazil, Canada, Chile, Colombia, Costa Rica, Ecuador, El Salvador, Italy, Netherlands, India, Japan, Korea, Malaysia, Mexico, New Zealand, Panama, Singapore, Taiwan, Thailand, Trinidad and Tobago, and Venezuela.
These words name no state.
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
The words say it went outside the United States too.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Terminated, in FDA’s file.
“FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.”
openFDA, on “Terminated”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Aug 21, 2019.
- FDA classified it on Nov 22, 2019.
- FDA’s Enforcement Report published it on Dec 4, 2019.
- FDA terminated it on Jul 21, 2021.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Zimmer Biomet, Inc., of Warsaw, IN.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 45,998 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
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U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.