Zimmer Manufacturing B.V.: Product 60 consists of all product under product code: HSB and same usage: Item no: 225207055 RECON SCREW LG 5.5MM DIA 225207555 RECON SCREW LG 5.5MM DIA 225208055 RECON SCREW LG 5.5MM DIA 225208555 RECON SCREW LG 5.5MM DIA 225209055 RECON SCREW LG 5.5MM DIA 225209555 RECON SCREW LG 5.5MM DIA 225210055 RECON SCREW LG 5.5MM DIA 225210555 RECON SCREW LG 5.5MM DIA 225211555 RECON SCREW LG 5.5MM DIA 225212055 RECON SCREW LG 5.5MM DIA 225213055 RECON SCREW LG 5.5MM DIA Usage: An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.

Recall number

Z-1158-2016

Recalling firm

Zimmer Manufacturing B.V.

Product

Product 60 consists of all product under product code: HSB and same usage: Item no: 225207055 RECON SCREW LG 5.5MM DIA 225207555 RECON SCREW LG 5.5MM DIA 225208055 RECON SCREW LG 5.5MM DIA 225208555 RECON SCREW LG 5.5MM DIA 225209055 RECON SCREW LG 5.5MM DIA 225209555 RECON SCREW LG 5.5MM DIA 225210055 RECON SCREW LG 5.5MM DIA 225210555 RECON SCREW LG 5.5MM DIA 225211555 RECON SCREW LG 5.5MM DIA 225212055 RECON SCREW LG 5.5MM DIA 225213055 RECON SCREW LG 5.5MM DIA Usage: An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.

Status

Terminated

Initiated

2016-01-11

Posted

2016-03-12

Terminated

2017-04-13

Reason

As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile.

Root cause

Packaging

Action

Zimmer Biomet sent an Urgent Medical Device Recall Letter, dated January 11, 2016, to Distributors, Sales Representatives, Operation Managers, and Risk Managers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to 1.Review the notification and ensure that relevant personnel are aware of the contents. 2. Assist your Zimmer Biomet sales representative with the quarantine of any affected product. 3. Your Zimmer Biomet sales representative will remove the recalled product from your facility. 4. Complete and return the attached Certificate of Acknowledgment form to corporatequality.postmarket@zimmerbiomet.com. 5. If after reviewing this notification you have further questions or concerns please call Customer Service at 1-800-348-2759, or contact your Zimmer Biomet Sales Representative.

Quantity

1394

Distribution

US Nationwide Distribution

Lot, serial or model codes

lot no.: 61893774 61968082 62153448 62296426 62296426N 61983672 62153447 61827280 61920741 61964034 62108027 62108029 62153449 61835479 61878730 61878732 61940068 61940069 62121105 62121106 62121107 62121108 61621138 61878733 61929350 61940070 61940071 62086349 62086350 62086351 62086353 62086355 62086356 62153450 61763506 61878734 61878735 61940072 62121116 62121117 62121118 62121119 61878736 61929351 61940076 62121110 62121111 62121112 62121113 62103433 61597004 61597004N 61906259 61895931 61895932 61895933 61895935 61912972 61912975 61912976 61912977

510(k) numbers

["K965098"]

PMA numbers

not on file

Product code

HSB

Firm FEI

1000132037

Firm city

Mercedita

Firm state

not on file

Firm country

PR

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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