Z-0073-2010

Biotrak PLLA Pin, Resorbable Fixation System, Biotrak 20 mm Pin; sterile pin packaged in sterile bag...

Name: Z-0073-2010 Biotrak PLLA Pin, Resorbable Fixation System, Biotrak 20 mm Pin; sterile pin packaged in sterile bag...
Creator: Acumed LLC
Published: 2009-08-21
License: https://open.fda.gov/license/

Acumed LLC / initiated 2009-08-21 / Terminated / root cause: labeling and UDI

FDA source

Acumed LLC began a recall of Biotrak PLLA Pin, Resorbable Fixation System, Biotrak 20 mm Pin; sterile pin packaged in sterile bag, enclosed within a box labeled Biotrak Resorbable Fixation... on 2009-08-21. The reason FDA records is "Labeling may contain 2 lot numbers and 2 model numbers. It was observed that the box top label (30170060-S, W67391) does not match the two side labels (3010320-S, W67385). The part and patient labeling inside the box...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0073-2010
Status: Terminated
Initiated: 2009-08-21
Posted: 2009-10-23
Terminated: 2010-11-06
Recalling firm: Acumed LLC
Product: Biotrak PLLA Pin, Resorbable Fixation System, Biotrak 20 mm Pin; sterile pin packaged in sterile bag, enclosed within a box labeled Biotrak Resorbable Fixation System Biotrak 20 mm Pin REF 30170320-S Manufactured or Distributed by: ACUMED LLC 5885 NW Cornelius Pass Rd Hillsboro, OR 97124. The Acumed resorbable fixation devices are designed to provide fixation of specific fractures, osteotomies, and arthrodeses while they heal.
Product code: HWC Screw, Fixation, Bone
Reason for recall: Labeling may contain 2 lot numbers and 2 model numbers. It was observed that the box top label (30170060-S, W67391) does not match the two side labels (3010320-S, W67385). The part and patient labeling inside the box match the side labels (30170320-S, W67385).
Root cause tag: labeling and UDI
FDA root cause: Pending
Action: Urgent Notice: Device Recall Letters dated August 21, 2009 were sent to all consignees advising of the issue and and required action. Customers are to identify and quarantine the product having the affected lot code(s). Customers are to also return all product from the specified lot(s) to Acumed immediately. If product was further distributed, then those consignees should be notified of the recall and return of the product(s) should be requested. Questions should be directed to Acumed Customer Service at 1-888-627-9957.
Quantity in commerce: 125
Distribution: Worldwide Distribution -- USA and South Africa.
Product codes and lots: Lot W67385, Model #30170320-S, expiration 8/2010 (two side labels correctly state 30170320-S, Lot W67385; top label may incorrectly state 30170060-S, lot W67391).

Product code HWC

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About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)